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VULCAN™ Generator - Frank`s Hospital Workshop

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1. 00 00sec cece eee 16 Replacing Fuses orc arscgau ieee tenes gestae 16 Software Upgrades 0 00 0000 cece eee 7 Replacing Returning Worn or Defective Equipment or Parts 0 0 200 e ee 7 Preventative Maintenance 00 0 7 Calibration of Temperature Measurement Circuit 7 Troubleshooting 0 00 cece eee eee eee 18 24 Generator Control Unit 0 0 00 0002 e eee 18 Alarm and Fault Messages 18 21 Observed Problems 0 000s eee eee 22 24 Technical Specifications 0 cece eee eee 25 Ordering Information 0 0 0 eee eee ee eee 26 Output Charts ss vas o6 ssc essensen ee 27 28 Output Voltage vs Output Control oases 27 Power Output vs Output Control Cut Mode 27 Power Output vs Output Control Coag Mode 28 Power Output vs Load Resistance 28 4 1061526 Rev C VULCAN Generator Operations Service Manual Introduction Device Description Indications for Use Contraindications Warnings Introduction The Smith amp Nephew VULCAN Generator is designed to provide finely controlled radiofrequency RF energy for the coagulation cutting ablation and hemostasis of soft tissue during a variety of surgical procedures The generator control unit is specifically designed for use with Smith amp Nephew temperature controlled and power controlled probes
2. Device Description The generator control unit is a line voltage powered radiofrequency generator capable of delivering up to 200 watts of power The generator control unit includes a neutral electrode monitor NEM to monitor split grounding pad contact quality It is designed to be used only with Smith amp Nephew temperature controlled cutting and ablation probes and includes the following features e Two RF output modes Temperature Control Mode where the output power is software controlled to maintain a specified tissue temperature and Power Control Mode used for cutting ablation and hemostasis e Numerical displays for impedance set power delivered power set temperature actual temperature set cut set coagulation and preset selections e Message display for text messages e Indicators for electrode type monopolar or bipolar mode Temperature Control or Power Control stand by RF power on RF output type cut or coagulation fault and split grounding pad monitoring NEM monitors the split grounding pad connection during surgery discontinuing RF delivery if a fault in the NEM monitor circuit is detected e A probe recognition system the generator control unit automatically selects the appropriate mode and preset settings for the probe type The Smith amp Nephew VULCAN Generator software can be upgraded at the customer s location with a Smith amp Nephew supplied PCMCIA card For information reg
3. Replace if evidence of deterioration is noted CAUTION The Smith amp Nephew VULCAN Generator is designed specifically for use only with Smith amp Nephew arthroscopic radiofrequency probes Do not use other devices with the generator control unit Note Smith amp Nephew VULCAN Extension Cables may only be reused in accordance with the instructions in the Cleaning and Sterilization section Note Contact Smith amp Nephew or visit the Smith amp Nephew web site for the most current list of available arthroscopic RF products IMPORTANT Accessories connected to the generator control unit must be capable of withstanding the highest RF peak voltage output Refer to Output Charts section for suitable ratings prior to connection and or RF application 26 1061526 Rev C VULCAN Generator Operations Service Manual Output Charts Output Voltage vs Output Control 600 5 AS 500 400 Output x Open Cut Voltage P 300 2 Kohms Cut ea 0 Open Coag W A 2 Kohms Coag 200 L 100 pe 0 0 20 40 60 80 100 120 140 160 180 200 Power Set W Power Output vs Output Control Cut Mode 200 5 160 120 2kQ E ik 5000 Power 2000 Out W 1009 e 502 80 250 13Q 40 o9 i 20 40 60 80 100 120 140
4. and a grounded AC power source WARNING Check that the electrical equipment is properly grounded i e plugs contain a ground prong The generator control unit must be plugged into a hospital grade AC outlet 2 Inspect the footswitch for any obvious defects Connect the footswitch cable to the appropriate connector on the rear of the generator control unit 3 Prepare the patient using standard technique for electrosurgical procedures The patient s entire body including extremities must be insulated against contact with grounded metal parts and sufficient layers of electrically insulating sheets should be placed underneath the patient A waterproof cover should be placed over the insulating sheets with absorbent sheets placed between the patient and the waterproof cover to absorb any moisture A WARNING The operating table should be grounded 4 For monopolar procedures affix the split grounding pad to the patient according to the instructions found in the pad packaging Select a well vascularized application site in close proximity to the surgical site Avoid bony or hairy prominences Shave clean and dry the application site as needed Apply the pad firmly assuring full adhesion and contact with the patient s skin After the pad is properly applied to the patient connect the pad to the NEM connector on the control unit front panel Note It is important that the split grounding pad be connected to the generato
5. arms and body of the patient should be avoided Insertion of dry gauze or its equivalent is recommended The probe cables and extension cable should be positioned in such a way that contact with the patient or other leads is avoided Probes not in use should be stored isolated from the patient Incorrect actual temperature readings may result in improper treatment Verify that the TEMPERATURE display reads the expected value room temperature or body temperature prior to treatment If the TEMPERATURE reading is not accurate check the device and connectors for damage moisture or contamination Clean or replace as needed If desired tissue effect is not being achieved do not increase power beyond the normal range without first inspecting the integrity of the probe and neutral return electrode To prevent electric shock unplug the control unit from the electrical outlet before attempting to replace the fuses To avoid fire hazard use only fuses of the correct type voltage rating and current rating To prevent electric shock do not remove the control unit cover There are no user serviceable components inside Dismantling the equipment will void the warranty Refer servicing to qualified Smith amp Nephew personnel 6 1061526 Rev C VULCAN Generator Operations Service Manual Precautions Unpacking and General Inspection Precautions U S Federal law restricts this device to sale by or oxy on the or
6. fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol gt Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones land mobile radios amateur radios AM and FM radio broadcasts and TV broadcasts cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the VULCAN Generator is used exceeds the applicable RF compliance level above the VULCAN Generator should be observed to verify normal operation If abnomal performance is observed additional measures may be necessary such as reorienting or relocating the VULCAN Generator gt Over the frequency range 150 KHz to 80 MHz field strengths should be less than 3 V m Applies only to Smith amp Nephew VULCAN Generator REF 7210812 Does not apply to Smith amp Nephew VULCAN Generator REF 7209673 VULCAN Generator Operations Service Manual 1
7. manufacturer s Instructions for Use e Do not exceed the RF duty cycle for the probe e Do not withdraw the probe while energy delivery is activated this may result in an unintended patient burn or ignition of flammable materials e When using RF surgical equipment keep the working part of the RF probe s active electrode in the field of view to avoid accidental RF burns Avoid contact of the probe with metal parts of the scope and other conductive accessories by ensuring before activation of the RF probe that the active electrode is at sufficient distance from the tip of the scope e Failure of the radiofrequency surgical equipment could result in unintended increase of output power e Burns to the surgeon s hands may be possible if a probe comes into contact with a metal instrument or surface e Use of electrosurgery in patients with internal or external pacemakers implantable defibrillators or monitoring equipment may require special considerations The attending cardiologist and or the pacemaker manufacturer should be consulted prior to surgery The operating table should be grounded During monopolar electrosurgery the patient should not come into contact with any metal parts which are grounded or which have appreciable capacitance to earth operating tables supports etc The use of anti static sheeting is recommended for this purpose During monopolar electrosurgery skin to skin contact i e between the
8. on an annual basis If it is found to be out of specification the device should be returned to Smith amp Nephew for repair The generator performs a self test during power up to verify power calibration There is an internal 100 ohm resistor which is measured and compared to its specified value The generator goes into a Fault Mode if the calibration is out of specification In addition the thermocouple amplifying circuits are checked for calibration However there is no check on the absolute temperature measured by a temperature probe therefore this calibration must be manually checked Equipment e Thermometer e TAC S Probe with connecting cable e Beaker Procedure 1 Fill the beaker with cool water 10 30 C 2 Use the thermometer to measure and record the temperature of the cool water 3 Turn on the control unit and connect the cable of the test TAC S Probe Verify that the control unit goes into the Temperature Control Mode The TEMPERATURE should display room temperature 4 Immerse the tip of the TAC S Probe in the water and record the actual temperature 5 Repeat steps 1 4 using hot water 50 90 C The TEMPERATURE reading with the TAC S Probe should be 3 C of the thermometer reading in both cases If a greater difference is observed contact Smith amp Nephew for assistance VULCAN Generator Operations Service Manual 1061526 Rev C Troubleshooting Troubleshootin
9. than 500 ohms the probe was defective If IMPEDANCE is less than 500 ohms the control unit may need service Contact Smith amp Nephew Reduce output power or increase idle time between periods of RF power delivery use of the system either for an excessive period of time or at excessive power levels may cause this fault Call Smith amp Nephew Technical Support at 1 800 343 5717 in the U S or your local Smith amp Nephew representative VULCAN Generator Operations Service Manual 1061526 Rev C Troubleshooting continued Observed Problems If no alarm or fault messages are displayed and the generator is not performing as expected check the following list of conditions for possible remedies Contact Smith amp Nephew if the suggested remedies do not correct the condition Insufficient tissue Possible cause Temperature never reaches SET TEMP response tissue not e Ensure probe tip is in direct visual contact with the target tissue Probe should be reaching desired moved slowly across the tissue temperature e Ensure footswitch is continuously depressed during energy delivery e ACTUAL PWR should reach or approach SET POWER e Increase SET TEMP by 5 C and observe tissue response Check IMPEDANCE reading 1 IF IMPEDANCE is less than 40 ohms 20 ohms depending on probe software will reduce power to 5 watts e Ensure that probe tip is NOT in contact with any metal cannula conductor or instrumen
10. that the pad is properly connected to the front of the control unit To test for proper operation of the NEM circuitry unplug the neutral electrode and connect a 100 ohm non inductive resistor across the two pins of the neutral electrode connector The impedance should be sufficiently high to clear the alarm If the alarm persists contact Smith amp Nephew VULCAN Generator Operations Service Manual 1061526 Rev C Troubleshooting continued Alarm and Fault Messages continued POWER FACTOR LOW RF output is reduced to Keep active electrode away Output power reduced below 5 watts whenever the from metallic surfaces during calculated power factor is use less than 0 2 Can t use COAG pedal The use of the COAG pedal Use the CUT pedal with this probe is not supported with the connected probe RF Disabled No A footswitch was pressed Connect a probe prior to Probe Detected when no probe was pressing a footswitch connected Cannot use Temp Cont A thermocouple was Use the Temperature Control Probe in Power Mode detected on a probe Mode Cannot use CUT pedal The CUT pedal was used Use the COAG pedal with Electroblade with the Smith amp Nephew DYONICS Electroblade Resector Footswitch Stuck On One or both footswitches e Check each footswitch to was activated during start make sure a cord or other up object is not interfering with the footswitch connection Reset the control un
11. 061526 Rev C 3 Warranty Smith amp Nephew products are guaranteed to be free from defects in material and workmanship for the warranty period for a particular product beginning from date of invoice Refer to the current Smith amp Nephew Product Catalog or contact Smith amp Nephew Customer Service for specific warranty information This limited warranty is restricted to repair or replacement by Smith amp Nephew at its option of any product found to be defective during the warranty period Damage inflicted to a product by the user that causes it to be unsuitable for refurbishment may result in additional charges regardless of warranty status All warranties apply to the original buyer only In no event shall Smith amp Nephew be liable for any anticipated profits consequential damages or loss of time incurred by the buyer with the purchase or use of any product NO OTHER WARRANTY EXPRESSED OR IMPLIED IS GIVEN Service Replacement Units Warranty Smith amp Nephew service replacement units are warranted to be free from defects in material and workmanship for the warranty period for a particular product beginning from date of invoice Refer to the current Smith amp Nephew Product Catalog or contact Smith amp Nephew Customer Service for specific warranty information Service Replacement Program Smith amp Nephew offers a 24 hour Service Replacement Program for its products to minimize downtime in your operating
12. 160 180 200 Power Set W VULCAN Generator Operations Service Manual 1061526 Rev C Output Charts continued Power Output vs Output Control Coag Mode 200 5 x 160 fH e 2kQ 120 Eiko 7 a 500Q Power gt lt 2002 Out W 1009 e 502 80 2 e 25Q 13Q r r 160 180 200 Power Set W Power Output vs Load Resistance 200 160 e 120 Full Cut Power oa oan m Half Cut W Full Coag Half Coag 80 Lal a oe 9 NR m 40 al o 0 200 400 600 800 1000 1200 1400 1600 1800 2000 Resistance ohms 28 1061526 Rev C VULCAN Generator Operations Service Manual Guidance and Manufacturer s Declaration Guidance and Manufacturer s Declaration Electromagnetic Emissions The Smith amp Nephew VULCAN Generator is intended for use in the electromagnetic environment specified below The customer or user of the VULCAN Generator should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 2 The VULCAN Generator must emit electromagnetic CISPR 11 energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions C
13. OPEN TC refers to an open thermocouple circuit Alarm Cannot use CUT pedal in Temp Control mode Alarm RF Disabled Check Return Electrode Alarm LOW LOAD IMPEDANCE Output power reduced Alarm NEM CIRCUIT SHORTED Use split pad return Call Smith amp Nephew Technical Support at 1 800 343 5717 in the US or your local Smith amp Nephew representative RF output is not allowed in the Temperature Control Mode unless a valid temperature measurement is returned from the probe s temperature sensor RF output is disabled in the Temperature Control Mode if the yellow CUT footswitch is pressed RF output is disabled in any monopolar mode if the impedance between the electrodes on the split grounding pad is greater than the calculated threshold RF output is reduced to below 5 watts whenever the measured load impedance is less than 40 ohms or 20 ohms depending on the probe If the impedance calculated during NEM initialization is less than 5 ohms the unit indicates a NEM contact failure e Check probe connection to generator control unit e Replace probe Use COAG pedal Check that the return electrode is properly applied to the patient and that the cable is properly connected to the generator control unit Keep active electrode away from metallic surfaces during use e Check that split grounding pad is being used Check that the split grounding pad is properly applied to the patient and
14. Operations Service Manual SU smith amp nephew VULCAN Generator CE Glossary of Symbols NON STERILE Non Sterile Dangerous Voltage Danger of electric shock CAUTION U S Federal law restricts this device to sale by or on the order ONLY of a physician gt Fragile handle with care This Way Up Keep Dry Neutral Return Electrode Connector Split Grounding Pad Defibrillator Proof Type BF Equipment 5 F 9 2 e Equipotentiality 2 Alternating Current Non ionizing Electromagnetic Radiation A p Protective Earth ground 2 tx O b amp st gt gt og Footswitch EU Not for general waste UL Classification Fuse Amplitude Control ON OFF Up and Down Buttons Temperature Range Humidity European Representative Service lifetime in years VULCAN Generator Operations Service Manual 1061526 Rev C Preface Table of Contents Preface This manual provides the information required to operate and maintain the Smith amp Nephew VULCAN Generator It is essential that all the information in this manual and on the generator label is read and understood before using or maintaining the equipment Ta ble of Contents Guidance and Manufacturer s Declaration 29 31 Electromagnetic Emissions 02005 29 Glossary of Symbols 0 00 cece cece eee eee 3 Guidance for Separ
15. RF interference for which the user is held responsible e The generator control unit must be powered from a properly grounded 120 240 VAC single phase supply Excessive risk leakage current may result if this equipment is connected to other than the manufacturer s recommended power distribution system e Risk of burns or fire Do not use near conductive materials such as metal bed parts inner spring mattresses etc VULCAN Generator Operations Service Manual 1061526 Rev C 5 Warnings continued e Check that the electrical equipment is properly grounded i e plugs contain a ground prong The generator control unit must be plugged into a hospital grade AC outlet e Safe use of monopolar electrosurgery demands proper grounding of the patient and proper insulation between the patient and any metal surfaces A split pad with a surface area of at least 20 square inches 130 cm is required Valleylab REM pads REF 7209687 meet this dimensional requirement and are recommended by Smith amp Nephew for use with the VULCAN Generator Pads with a surface area of less than 20 square inches may have a lower dispersive effect It is the responsibility of the user to qualify any alternate ground pad e Use of an inadequate ground pad or incorrect placement of the ground pad may result in a burn injury to the patient e Improper probe usage may result in patient burns at the return pad To avoid this follow the
16. Recognition The Smith amp Nephew VULCAN Generator software recognizes which type of Smith amp Nephew probe is connected to the control unit by reading a sensor in the probe When a probe is connected to the control unit the software automatically switches to the appropriate control MODE and PRESET setting if supported for that specific probe The SET TEMP SET POWER SET CUT and SET COAG settings may be changed from their preset values using the up down arrows next to the respective displays if supported by the probe The Smith amp Nephew VULCAN Generator software also contains temperature and power limits for each probe type The SET TEMP SET POWER SET CUT and SET COAG settings cannot be set to values outside the range programmed in the software This feature ensures that each probe type is used within its safe limits of operation VULCAN Generator Operations Service Manual 1061526 Rev C 13 Controls and Functions Instructions for Use Energy Delivery Tone A tone sounds whenever RF energy is delivered Volume is adjustable using the volume control knob on the control unit rear panel In Power Control Mode the tone is a steady sound while RF energy is delivered In Temperature Control Mode the tone sounds slowly while probe temperature is increasing The tone sounds more rapidly as the set temperature is approached The tone is rapid and steady when the set temperature is reached and while it is he
17. TURE If TEMPERATURE is not close to SET TEMP the thermocouple in the probe may be defective RF delivery is disabled in this condition FAULT indicator light Turn control unit off and back on If light stays on contact Smith amp Nephew stays on and the generator emits a continuous tone RF interferes with other 1 Ensure the probe or neutral electrode cables do not cross the cables from the equipment affected equipment Changing the settings on the affected equipment may alleviate interference Plug the affected equipment into a separate power outlet Delivered power IFIMPEDANCE reading is 40 ohms or lower 20 ohms depending on probe ensure displayed on the that the probe tip is NOT in contact with any metal conductor or instrument ACTUAL PWR readout Turn the control unit off and back on If issue does not resolve itself the control unit will not go above may need repair Contact Smith amp Nephew 5 watts Temperature reads OP 1 Ensure that the control unit is in Temperature Control Mode and a temperature Ensure that the probe extension cable is properly plugged into the jack and that controlled probe is the probe is properly plugged into the other end of the cable the white markers being used should line up and there should be a positive click lf steps 1 2 do not solve the problem replace the extension cable If step 3 does not solve the problem replace the probe Call Smith amp Nephew
18. Technical Support at 1 800 343 5717 in the US or your local Smith amp Nephew representative VULCAN Generator Operations Service Manual 1061526 Rev C Troubleshooting continued Observed Problems continued Temperature consistently 1 Decrease SET POWER 1 5 watts overshoots SET TEMP 2 Maintain constant tissue contact and steady probe movement NEM light is red 1 The split grounding pad is not properly attached Make sure that a split grounding pad is properly placed and is connected to the control unit Replace the split grounding pad being careful to check for proper application to the patient Auto Probe Recognition Check probe cable connection does not work or no Change the cable if necessary readings are displayed Turn power off then on again on the control unit Change the probe if necessary Cannot set desired The control unit includes circuitry to detect the type of surgical probe that is power or temperature connected and to limit the maximum power temperature settings based on the level intended use and ratings of the probe Check the message display to ensure that the control unit has properly detected the type of probe that is connected Indication of an incorrect probe may be the result of either a defective cable or probe 24 1061526 Rev C VULCAN Generator Operations Service Manual Technical Specifications Technical Specifications Input Power 100 240 V 50 60 H
19. arding software upgrades please contact your authorized Smith amp Nephew representative Indications for Use The Smith amp Nephew VULCAN Generator is indicated for general surgical purposes including orthopedic and arthroscopic applications for coagulation ablation and hemostasis of soft tissues in combination with Smith amp Nephew temperature controlled cutting and ablation probes Contraindications There are no known absolute contraindications to the use of electrosurgery The use of the Smith amp Nephew VULCAN Generator and accessories is contraindicated when in the judgment of the physician an electrosurgical procedure would be contrary to the best interest of the patient A Warnings e Itis the surgeon s responsibility to be familiar with the appropriate surgical techniques prior to use of this device e Read these instructions completely prior to use e DANGER Risk of explosion if used in the presence of flammable anesthetics skin preparation agents or biointestinal gases e Hazardous electrical output This equipment should be used only by qualified medical personnel trained in the use of electrosurgery devices e This device has been tested and verified to comply with the IEC 60601 2 2 This exceeds the requirements specified by FCC part 18 for ISM equipment This device is intended for operation in a medical facility only Usage in a residential environment will likely cause unacceptable
20. ation Distances 00e00 29 Prefaco nonon ees eh SPER SN 4 Electromagnetic Immunity 0 ec0cecsvceee 30 31 Introduction sxssdassssskersrsseteskenesenenaedeed eg 5 i ae Warranty 0 eee eee ee eee eens Back Cover Device Description 0 cece eee eee eee eee 5 Service Replacement Units Warranty Back Cover Indications for Use 06 eee cece eee tee eeeeees 5 SLA Service Replacement Program Back Cover Contraindications Kip des EAN 5 Repair Service Program 0seeeseseees Back Cover WarmmiNgs sexx oa EEEE EEEO EE Sone Pees a 5 6 Precautions vade de fre seeded nnneretoedens 7 Figures Unpacking and General Inspection 7 1 Control unit front panel 0 cccccccceceeeeeuceeeees 8 Front Panel Layout 0 cece cece eee eee eee 8 9 2 Control unit rear panel o o aoaaa aoaaa 10 Rear Panel Layout oes soda EN hb be Bee anaes RS Ea 10 3 AC receptacle with fuSCS eccccceceeceeeeues 16 Preoperative Setup 00 cee eee eee eee eee 1 Operational Modes 00 0 cece cece eee e eee 12 Power Delivery Modes 0ceeee cece eees 12 Controls and Functions 0 eee e eee 13 14 Instructions for Use 00 cece cece ee eee teenies 14 15 Cleaning and Sterilization 0 15 16 Service and Maintenance 2220000 16 17 Service Philosophy 0
21. deliver RF power 2 Connect the selected Smith amp Nephew probe to the probe connector on the control unit front panel If the probe includes an integrated cable insert the cable connector with the thumb groove up For probes without an integrated cable connect the probe to the extension cable A click may be heard Tug gently on the extension cable to ensure proper connection Connect the other end of the probe cable into the probe connector Note ELECTROBLADE Resectors with a two prong Valleylab plug end can be plugged into the ELECTROBLADE Adaptor for use with the VULCAN Generator 3 Verify that the selected probe s name is presented on the message display The generator software will recognize the probe type by reading a sensor in the probe and will automatically switch to the appropriate power output MODE and setting for that specific probe WARNING Burns to the surgeon s hands may be possible if a probe comes into contact with a metal instrument or surface CAUTION Check the probe and extension cable connections for the presence of liquid before use or whenever a probe is connected or disconnected during a procedure Liquid may enter the connection during a procedure ANY liquid can cause the connections to short resulting in erroneous probe recognition or damage to the probe cable or generator control unit CAUTION Check the generator control unit s LCD message display to ensure that the proper probe
22. der of a physician Prior to each use inspect the device to ensure it is functioning properly and not damaged Do not use a damaged device The Smith amp Nephew VULCAN Generator is designed specifically for use only with Smith amp Nephew arthroscopic radiofrequency probes Do not use other devices with the generator control unit Check the probe and extension cable connections for the presence of liquid before use or whenever a probe is connected or disconnected during a procedure Liquid may enter the connection during a procedure ANY liquid can cause the connections to short resulting in erroneous probe recognition or damage to the probe cable or generator control unit Check the generator control unit s LCD message display to ensure that the proper probe identification and settings are displayed prior to beginning any procedure Use the lowest RF power setting necessary to achieve the desired tissue effect This equipment is designed and tested to minimize interference with other electrical equipment However if interference occurs with other equipment it may be corrected by one or more of the following measures Reorient or relocate this equipment the other equipment or both Increase the separation between the pieces of equipment Connect the pieces of equipment into different outlets or circuits Consult a biomedical engineer This equipment contains electronic printed circuit assembl
23. f the control unit may be wiped down with any liquid disinfecting solution non flammable solution should be used Care must be taken not to allow any liquid to pass into any electrical connections or the interior of the control unit Let the surfaces dry thoroughly before plugging in the device DO NOT steam sterilize the control unit DO NOT immerse the generator control unit in glutaraldehyde or other liquid sterilant or disinfectant DO NOT submerge control unit for any reason Smith amp Nephew VULCAN Extension Cable The Smith amp Nephew VULCAN Extension Cable REF 7209693 is reusable and may be cleaned and sterilized as follows 1 Rinse the cable with warm running tap water for a minimum of two minutes or until all visible debris is removed 2 Place the cable in a bath containing Klenzyme enzymatic detergent prepared according to the manufacturer s instructions for two minutes Make sure that there is sufficient detergent to cover the cable 3 Rinse the cable thoroughly under warm running tap water for one minute 4 Prepare a solution of commercially available manual cleaner i e Manu klenz according to the manufacturer s instructions Gently scrub the cable using a soft non metallic brush while the cable is immersed in the cleaning solution VULCAN Generator Operations Service Manual 1061526 Rev C Cleaning and Sterilization Service and Maintenance 5 Rinse the cable thoroughly under
24. g Generator Control Unit The generator control unit includes a message display that provides a text description of any alarm or fault messages If the system is not operating as expected check the message display WARNING To prevent electric shock do not remove the control unit cover There are no user serviceable components inside Dismantling the equipment will void the warranty Refer servicing to qualified Smith amp Nephew personnel Alarm and Fault Messages The generator detects two types of error conditions alarms and faults An alarm is generated to inform the user that the output of the device is being disabled to prevent injury to the patient or damage to the device Alarms are automatically cleared once the alarm condition returns to its acceptable value A fault is a more serious error condition and typically occurs as a result of a hardware failure such as a stuck footswitch or a conversion circuit that is out of calibration The FAULT indicator light will be illuminated and requires that the control unit be reset by cycling power Refer to the Troubleshooting section for those faults that can be corrected by the user If a fault other than those listed occurs contact Smith amp Nephew for assistance 18 1061526 Rev C VULCAN Generator Operations Service Manual Troubleshooting continued Alarm and Fault Messages continued Alarm OPEN TC RF disabled in Temp Control mode Note
25. ge Display Displays modes probe type alarms warnings or fault messages Probe Connector Accepts 8 pin Smith amp Nephew temperature controlled cutting ablation and hemostasis probes The Smith amp Nephew VULCAN Extension Cable REF 7209693 may be used with the generator control unit VULCAN Generator Operations Service Manual 1061526 Rev C Rear Panel Layout Rear Panel Layout Ne O ITPUT POWER 200 W Max 100 250 O Hz 2 GS V a gt 0 GA VULCAN 3 smith amp nephew I Generator Generator Generador G n rateur Generatore Generator Generator Gerador Generator Generator 47 A PEE REF 7210812 7 A 4 A G SN ZL 5 100 240V 50 60Hz 800vA Figure 2 Control unit rear panel Footswitch Connector Accommodates the generator footswitch cable supplied with the Smith amp Nephew VULCAN Generator Volume Control This knob adjusts the volume of the energy delivery tone Fan Outlet Carrying Handle Equipotential Compensator Terminal This terminal can be used to bring other equipment to the same case potential as the generator control unit Power Cord Connector The power cord connector is part of the power input module and accommodates the hospital grade power cord supplied with the Smith amp Nephew VULCAN Generator Fuse Access D
26. hicker or larger treatment areas may take longer to react 22 1061526 Rev C VULCAN Generator Operations Service Manual Troubleshooting continued Observed Problems continued OP in the Temperature 1 Ensure probe is connected properly see Preoperative Setup section for connection details With probe attached flex the cable near the generator control unit and probe end connections If OP changes to a temperature reading replace the cable If OP is still displayed after flexing the cable replace the probe No indicators or Be sure the control unit is plugged into a working electrical outlet and the power read outs are displayed switch at the rear of the unit is turned on when the control unit is 2 Unplug the control unit and inspect the integrity of the fuses in the rear panel turned on Fuses should only be replaced with those of the same type and rating according to the label on the rear of the unit or the Technical Specifications section RF power does not turn 1 Verify that the footswitch is properly connected to the back of the control unit on when footswitch is Verify that only one of the two footswitches is activated pressed In Temperature Control Mode only the blue COAG right footswitch is active Verify that the blue COAG footswitch is the one in use In Temperature Control Mode verify that a temperature controlled probe is in use Compare SET TEMP to TEMPERA
27. identification and settings are displayed prior to beginning any procedure 14 1061526 Rev C VULCAN Generator Operations Service Manual Instructions for Use Cleaning and Sterilization 4 Confirm that the NEM light is illuminated green If illuminated red check the split grounding pad to assure full adhesion and contact with the patient s skin 5 If using a temperature controlled probe proceed to step 6 If using a power controlled probe skip steps 6 8 and proceed directly to step 9 6 For temperature controlled probes check the temperature display to confirm expected values WARNING Incorrect actual temperature readings may result in improper treatment Verify that the TEMPERATURE display reads the expected value room temperature or body temperature prior to treatment If the TEMPERATURE reading is not accurate check the device and connectors for damage moisture or contamination Clean or replace as needed CAUTION Use the lowest RF power settings necessary to achieve the desired tissue effect 7 To begin RF energy delivery depress and hold the blue COAG footswitch for the type of power to be delivered according to the probe s Instructions for Use The green RF POWER ON and blue COAG indicator lights will illuminate WARNING If desired tissue effect is not being achieved do not increase power beyond the normal range without first inspecting the integrity of the probe and neutral return electr
28. ies At the end of the useful life of the equipment it should be disposed of in accordance with any applicable national or institutional related policy relating to obsolete electronic equipment Inspect all components including extension cables and power cord regularly for wear Pay particular attention to extension cable insulation Replace if evidence of deterioration is noted e Apparent low output or failure of the generator control unit to function properly at normal operating settings may indicate faulty application of the split grounding pad e When the generator control unit is used simultaneously with physiological monitoring equipment on the same patient any monitoring electrodes should be placed as far from the surgical electrodes as possible Needle monitoring electrodes are not recommended Monitoring systems using high frequency current limiting devices are recommended e Use only the power cord and connector specified for this unit e Electrical safety testing should be performed by a biomedical engineer or other qualified person e Do not immerse the footswitch cable Unpacking and General Inspection Carefully unpack and inspect all of the components shipped with the Smith amp Nephew VULCAN Generator The following should have been received Quantity Description 1 Smith amp Nephew VULCAN Generator REF 7210812 1 Smith amp Nephew VULCAN Footswitch REF 7209692 1 Hospital grade power cord count
29. it by turning it off and then back on again CJC Out of Range The cold junction Let generator reach room compensator CJC portion temperature of the thermocouple circuit has detected a room temperature outside the expected range of 10 35 C This may occur if the control unit was exposed to extreme temperatures 20 1061526 Rev C VULCAN Generator Operations Service Manual Troubleshooting continued Alarm and Fault Messages continued Output Load Shorted The load impedance fell below 40 ohms for longer than is permissible 20 ohms depending on probe RF Board Overtemp The temperature of the heat sink on the RF power control board has exceeded its specified threshold Aggressive e Check that probe is not shorted to the surgical cannula or arthroscope If no contact to the cannula arthroscope is seen the probe or probe cable may be defective Remove the probe from the surgical site and reset the control unit turn off then on With the probe in free air activate the footswitch and note the IMPEDANCE reading displayed If IMPEDANCE is less than 500 ohms either the probe or probe cable may be defective Replace the probe cable and repeat impedance check If IMPEDANCE is greater than 500 ohms the cable was defective If IMPEDANCE is still less than 500 ohms the probe may be defective Contact Smith amp Nephew Replace probe and repeat impedance check If IMPEDANCE is greater
30. lass A The VULCAN Generator is suitable for use in all CISPR 11 establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable Not applicable Applies only to Smith amp Nephew VULCAN Generator REF 7210812 Does not apply to Smith amp Nephew VULCAN Generator REF 7209673 Guidance and Manufacturer s Declaration Guidance for Separation Distances Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Smith amp Nephew VULCAN Generator The VULCAN Generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the VULCAN Generator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the VULCAN Generator as recommended below according to the maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter m 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Rated Maximum Output Power of Transmitter W d 12VP d 12vP d 23VP 0 01 012 0 12 0 23 01 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For
31. ld Any variation in tone speed signals the user that the probe temperature is not at the target temperature Fault Tone The fault tone sounds briefly during generator control unit startup and in the event of a warning or fault condition The volume of the fault tone cannot be adjusted by the user Footswitch Connector A dual electrically activated footswitch is provided to control RF energy delivery The blue COAG right pedal is used with temperature controlled probes and with SET COAG in Power Control Mode The yellow CUT left pedal is used with cutting ablation probes in Power Control Mode Temperature Control Mode Yellow CUT pedal inactive Blue COAG pedal enables coagulation output with temperature control Power Control Mode Yellow CUT pedal enables cut output Blue COAG pedal enables coagulation output Instructions for Use 1 Turn the control unit on using the on off switch on the rear panel The generator will perform a series of system self tests to determine if it is performing properly If any of these tests fail the FAULT indicator will illuminate and a continuous tone will sound Contact Smith amp Nephew Customer Service if any system self test fails Inspect the front panel displays for any system indicator warnings or messages After completing the self tests the generator will default to Stand By Mode All the displays on the front panel will be blank and the generator will not be able to
32. mation Each Smith amp Nephew VULCAN Generator system country specific includes a VULCAN Generator country specific power cord footswitch and country specific Operations Service Manual The International System REF 7210869 includes a European Continental power cord REF Description 7210868 Smith amp Nephew VULCAN Generator System U S 72201480 Smith amp Nephew VULCAN Generator System German 72201481 Smith amp Nephew VULCAN Generator System Spanish 72201482 Smith amp Nephew VULCAN Generator System French 7210872 Smith amp Nephew VULCAN Generator System Italian 72201484 Smith amp Nephew VULCAN Generator System Swedish 72201485 Smith amp Nephew VULCAN Generator System Dutch 72201486 Smith amp Nephew VULCAN Generator System Portuguese 72201487 Smith amp Nephew VULCAN Generator System Danish 72201488 Smith amp Nephew VULCAN Generator System Norwegian 72201489 Smith amp Nephew VULCAN Generator System Korean 7210870 Smith amp Nephew VULCAN Generator System UK 7210869 Smith amp Nephew VULCAN Generator System International Smith amp Nephew VULCAN Generator 7209693 Smith amp Nephew VULCAN Extension Cable 7209692 Smith amp Nephew VULCAN Footswitch 7209687 Split Grounding Pad 7209597 Probe Tip Bender 7210812 CAUTION Inspect all components including extension cables and power cord regularly for wear Pay particular attention to extension cable insulation
33. nstructions Note Product returned that is found to have been serviced by an unauthorized third party repair facility and or sterilized with a sterilization method other than one approved by Smith amp Nephew will incur additional costs regardless of warranty status It is not necessary to include accessory items i e power cords footswitches etc when returning a device for service Replacing Fuses WARNING To prevent electric shock unplug the control unit from the electrical outlet before attempting to replace the fuses WARNING To avoid fire hazard use only fuses of the correct type voltage rating and current rating Note Fuses that require frequent replacement may indicate an internal problem with the control unit If fuses continue to blow contact Smith amp Nephew Customer Service for assistance To Inspect and or Replace Fuses 1 Unplug the power cord from the power outlet and from the control unit 2 Use a screwdriver to open the fuse compartment door on the AC receptacle Figure 3 and slide out the two fuse carriers Refer to the Rear Panel Layout section to locate the AC receptacle on the rear panel 3 Replace fuses See Technical Specifications section for replacement fuse types 4 Reinsert the fuse carriers using the arrows on the inside of the fuse compartment door as a guide 5 Snap the fuse compartment door closed ON OFF Switch Fuse Carrier Figure 3 AC recep
34. ode 8 During energy delivery the generator sounds a fluctuating tone The tone pulsates slowly while probe temperature is ramping up to the SET TEMP The tone will sound more rapidly as the SET TEMP is approached The tone is rapid and steady when the SET TEMP is reached and while it is held Any variation in tone speed signals the user that probe temperature is not at the target temperature 9 To begin RF energy delivery in the Power Control Mode depress and hold the selected footswitch for the type of power to be delivered according to the probe s Instructions for Use Select the yellow CUT pedal for the cut output and the blue COAG pedal for the coagulation output The green RF POWER ON and yellow CUT or blue COAG indicator lights will illuminate Note During energy delivery in the Power Control Mode a steady tone will sound while RF energy is being delivered Different tones are generated for CUT and COAG WARNING Do not exceed the RF duty cycle for the probe 10 RF energy delivery may be discontinued at any time by releasing the footswitch To resume RF energy delivery press and hold the footswitch again WARNING Do not withdraw the probe while energy delivery is activated this may result in an unintended patient burn or ignition of flammable materials Cleaning and Sterilization Generator Control Unit The unit should be disconnected from the grounded AC outlet when being cleaned The exterior surface o
35. oor The fuse access door is part of the power input module See the Replacing Fuses section for instructions on fuse replacement To avoid hazards use appropriate fuses as specified in the Technical Specifications section On Off Switch Rocker type main power switch 1061526 Rev C VULCAN Generator Operations Service Manual Preoperative Setup Preoperative Setup WARNINGS DANGER Risk of explosion if used in the presence of flammable anesthetics skin preparation agents or biointestinal gases e Hazardous electrical output This equipment should be used only by qualified medical personnel trained in the use of electrosurgery devices e This device has been tested and verified to comply with the IEC 60601 2 2 This exceeds the requirements specified by FCC part 18 for ISM equipment This device is intended for operation in a medical facility only Usage in a residential environment will likely cause unacceptable RF interference for which the user is held responsible e The generator control unit must be powered from a properly grounded 120 240 VAC single phase supply Excessive risk leakage current may result if this equipment is connected to other than the manufacturer s recommended power distribution system e Risk of burns or fire Do not use near conductive materials such as metal bed parts inner spring mattresses etc 1 Plug the power cord into the rear panel power cord connector
36. ospital environment Note U is the a c mains voltage prior to application of the test level Applies only to Smith amp Nephew VULCAN Generator REF 7210812 Does not apply to Smith amp Nephew VULCAN Generator REF 7209673 30 1061526 Rev C VULCAN Generator Operations Service Manual Guidance and Manufacturer s Declaration continued Guidance and Manufacturer s Declaration Electromagnetic Immunity The Smith amp Nephew VULCAN Generator is intended for use in the electromagnetic environment specified below The customer or user of the VULCAN Generator should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 KHz to 80 MHz 3 V M 80 MHz to 2 5 GHz 3 Vrms 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the VULCAN Generator including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 12VP d 12v P 80 MHz to 800 MHz d 2 3v P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strength from
37. perature Control Mode SET CUT Display with Up Down Arrows SET CUT displays the maximum probe power output in watts increased or decreased using the SET CUT up down arrows Active only in Power Control Mode and the probe supports adjustment of SET CUT PRESET Display with Up Down Arrows PRESET displays the preset temperature and or power combination chosen and is adjustable using the PRESET up down arrows Settings are displayed as 1 2 3 etc Active in Temperature Control and Power Control Modes when the probe supports adjustment of PRESET ACTUAL PWR Display ACTUAL PWR displays the actual power in watts delivered to the probe Active only in Temperature Control Mode TEMPERATURE Display TEMPERATURE displays the actual temperature in degrees Celsius C measured at the tip of the probe Active only in Temperature Control Mode SET COAG Display with Up Down Arrows SET COAG displays the maximum probe power output in watts increased or decreased using the SET COAG up down arrows Active only in Power Control Mode and the probe supports adjustment of SET COAG SET BLEND Display with Up Down Arrows The SET BLEND mode is inactive for all probes FAULT Indicator Red Light FAULT illuminates when a fault condition is detected NEM Indicator Green or Red Lights NEM illuminates with a green light when the NEM circuit is correctly connected and with a red light when the NEM circuit is incorrectl
38. programmed settings for the probe type If a probe is not detected the generator control unit will default to PRESET 10 and the SET CUT and SET COAG displays will show the SET CUT and SET COAG values corresponding to this setting 12 1061526 Rev C VULCAN Generator Operations Service Manual Controls and Functions Controls and Functions SET POWER SET POWER may be changed by pressing the up down arrows located next to the SET POWER display Power may be adjusted from 1 50 watts Pressing the appropriate button repeatedly will adjust the power in increments of 1 watt holding the button down will scroll through the power settings automatically SET TEMP SET TEMP may be changed by pressing the up down arrows located next to the SET TEMP display Temperature may be set from 15 99 C Pressing the appropriate button repeatedly will adjust the temperature in increments of 1 C holding the button down will scroll through the temperature settings automatically SET CUT SET CUT inactive for ELECTROBLADE Resector may be adjusted by pressing the up down arrows located next to the SET CUT display Power may be adjusted from 1 200 watts or up to the preprogrammed limit for the probe type used Pressing the appropriate button repeatedly will adjust the power in increments of 5 watts holding the button down will scroll through the power settings automatically PRESET Temperature Control Mode Commonly used
39. r control unit after the pad is properly placed on the patient This allows the generator control unit to determine an accurate baseline split grounding pad contact quality measurement for a particular patient and will allow the system the greatest resolution in determining if a loss of split grounding pad contact occurs during the procedure A WARNINGS Safe use of monopolar electrosurgery demands proper grounding of the patient and proper insulation between the patient and any metal surfaces A split pad with a surface area of at least 20 square inches 130 cm is required Valleylab REM pads REF 7209687 meet this dimensional requirement and are recommended by Smith amp Nephew for use with the VULCAN Generator Pads with a surface area of less than 20 square inches may have a lower dispersive effect It is the responsibility of the user to qualify any alternate ground pad e Use of an inadequate ground pad or incorrect placement of the ground pad may result in a burn injury to the patient e Improper probe usage may result in patient burns at the return pad To avoid this follow the manufacturer s Instructions for Use VULCAN Generator Operations Service Manual 1061526 Rev C 11 Operational Modes Power Delivery Modes Operational Modes Power Up When the AC power to the generator control unit is turned on using the power switch on the rear panel the generator performs a series of system self te
40. relative humidity should be at least 30 Electrical fast transient 2 KV for power supply 2 kV for power supply Mains power quality Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec burst lines lines should be that of a typical IEC 61000 4 4 1 kV for input output 1 kV for input output Commercial or hospital lines lines environment Surge 1 kV differential mode 1 kV differential mode Mains power quality IEC 61000 4 5 2 kV common mode 2 kV common mode should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the VULCAN Generator requires continued operation during power mains interruptions it is recommended that that VULCAN Generator be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristc of a typical location in a typical commercial or h
41. room Our goal is to ship you a service replacement unit within 24 hours of your call during normal business hours For a Return Authorization RA number or for additional information on this program call Customer Service at 1 800 343 5717 in the U S or contact your authorized representative 24 hour shipment is not offered in all countries Repair Service Program For devices no longer under warranty repairs can be made by Smith amp Nephew or by an authorized agent Non warranty repairs will be made at the list price of replacement parts plus labor If requested we will provide an estimate of repair cost and time required for the repair before any work is done Repair items should be carefully disinfected repackaged marked with the Return Authorization RA number and returned postpaid to the appropriate Smith amp Nephew Service Center Smith amp Nephew Customer Service or your local authorized representative can provide shipping information Smith amp Nephew York Science Park Heslington York YO10 5DF United Kingdom Trademarks of Smith amp Nephew Certain marks registered U S Patent amp Trademark Office All other trademarks acknowledged Endoscopy www smith nephew com Smith amp Nephew Inc 1 978 749 1000 Andover MA 01810 1978 749 1108 Fax USA 1 800 343 5717 U S Customer Service 2006 2008 Smith amp Nephew Inc All rights reserved 02 2008 1061526 Rev C
42. ry specific 1 Smith amp Nephew VULCAN Generator Operations Service Manual REF 1061526 The Smith amp Nephew VULCAN Extension Cable REF 7209693 is available as an accessory for use with probes that do not include an integrated cable If any parts are missing or damaged please contact your authorized Smith amp Nephew sales representative Save the carton and packing materials in the event that a component needs to be returned for repair VULCAN Generator Operations Service Manual 1061526 Rev C Front Panel Layout Front Panel Layout SET POWER A IMPEDANCE 1 ACTUAL PWR Zy smith amp nephew 2 13 BI MONOPOLAR er V TEMPERATURE SET TEMP A SET CUT A SET COAG A vg A SET BLEND A Vv Vv Sa 19 RF POWER ON 18 1 VULCAN Generator Figure 1 Control unit front panel IMPEDANCE Display IMPEDANCE displays the impedance in ohms measured at the tip of the probe Active in both Temperature Control and Power Control Modes SET POWER Display with Up Down Arrows SET POWER displays the maximum probe power output in watts increased or decreased using the SET POWER up down arrows Active only in Temperature Control Mode SET TEMP Display and Up Down Arrows SET TEMP displays the target tissue temperature in degrees Celsius C increased or decreased using the SET TEMP up down arrows Active only in Tem
43. sts to determine if it is performing properly The self tests include ROM checksum RAM test Temperature measurement calibration test RF system test Display segments and indicators test If any of the system self tests fail the FAULT indicator on the front panel is illuminated and a continuous tone sounds Contact Smith amp Nephew if any system self test fails WARNING Failure of the radiofrequency surgical equipment could result in unintended increase of output power Stand By Mode Immediately after performing the self test the generator will default to Stand By Mode All of the displays on the front panel will be blanked and the generator control unit will not be able to deliver RF power while it is in Stand By Mode Fault Mode If a fault is detected at any time during the generator control unit s operation the FAULT indicator light will illuminate an alarm will sound an error code and text message will be displayed in the message display and the generator will enter the Fault Mode RF energy cannot be delivered and the control unit must be powered down then powered up again to exit from Fault Mode Power Delivery Modes Temperature Control Mode If the MODE button is pressed once while the generator is in Stand By Mode or if a temperature controlled probe is connected to the generator the generator will enter the Temperature Control Mode In Temperature Control Mode the Smith amp Nephew VULCAN Genera
44. t e Replace connector cable e Turn control unit off and then on again If problem is not resolved replace probe If IMPEDANCE is greater than 200 ohms e Ensure SET POWER is set to desired wattage e Inspect the neutral electrode for proper connection and patient placement see Preoperative Setup section Check the cable for proper connection e Disconnect and reconnect the extension cable at the control unit and at the probe See Preoperative Setup section for detailed instructions With the probe in contact with tissue and the generator delivering energy flex the cable near the generator and probe end connections If IMPEDANCE value dramatically changes 500 ohms replace cable If an arthroscopic fluid pump is being used e Reduce pump pressure and outflow as much as possible e Close seal or cap leaking cannulas to minimize flow through joint e Switch to gravity flow Inspect the probe shaft insulation e Clean coagulum off probe tip e If shaft insulation is not intact probe may be losing energy through the saline Replace probe If the probe was bent or aggressively handled replace the probe Insulation damage or thermocouple sensor in probe tip may be damaged Other considerations Older patients age greater than 40 years may exhibit a slower and less dramatic tissue response If patient has a history of prior surgery scar tissue may not respond to treatment Patient size may be a factor T
45. tacle with fuses 16 1061526 Rev C VULCAN Generator Operations Service Manual Service and Maintenance Software Upgrades For information regarding software upgrades please contact your local authorized Smith amp Nephew representative Replacing Returning Worn or Defective Equipment or Parts Contact Smith amp Nephew Customer Service to order replacement footswitches extension cables or any other accessory and for instructions on disinfection and return of worn out or defective equipment or parts Other than fuses the Smith amp Nephew VULCAN Generator has no customer serviceable parts For service please contact your representative or Smith amp Nephew Customer Service Preventative Maintenance The following inspections should be performed on an annual basis to ensure safe operation of the Smith amp Nephew VULCAN Generator Inspection of Cables Inspect the power cable and replace if signs of wear or abrasion are visible Inspection of Connectors Inspect all connectors on the control unit for signs of wear or damage Look specifically for bent or damaged pins loose fittings etc Contact Smith amp Nephew Customer Service for assistance if any damage is detected Calibration of Temperature Measurement Circuit There is no method for the user to alter the calibration of the temperature measurement hardware in the field However Smith amp Nephew recommends that this calibration be checked
46. temperature and power combinations are preprogrammed into the Smith amp Nephew VULCAN Generator software to allow the operator to quickly configure the generator control unit in Temperature Control Mode Use the PRESET up down arrows on the control unit front panel to select the desired setting The selected setting will be displayed in the front panel PRESET display and the corresponding temperature and power settings will be displayed in the SET TEMP and SET POWER displays PRESET Power Control Mode Commonly used SET CUT and SET COAG power combinations are preprogrammed into the generator software to allow the operator to quickly configure the control unit in Power Control Mode Use the PRESET up down arrows on the control unit front panel to select the desired setting The selected setting will be displayed in the PRESET display and the corresponding power settings will be displayed in the SET CUT and SET COAG displays PRESET is inactive for ELECTROBLADE Resector and GLIDER Articular Cartilage Probes SET COAG SET COAG inactive for GLIDER Articular Cartilage Probes may be adjusted by pressing the up down arrows located next to the SET COAG display Power may be adjusted from 1 200 watts or up to the preprogrammed limit for the probe type used Pressing the appropriate button repeatedly will adjust the power in increments of 5 watts holding the button down will scroll through the power settings automatically Auto Probe
47. tor software automatically adjusts energy delivery to maintain the tissue temperature indicated in the SET TEMP display Only monopolar temperature controlled probes may be used in Temperature Control Mode All Smith amp Nephew probes are equipped with a sensor that enables the generator control unit to detect the type of probe connected When a probe is connected the Smith amp Nephew VULCAN Generator software will read the sensor and automatically adjust power output and temperature parameters to the preprogrammed settings for the probe type If a probe is not detected the generator control unit will default to PRESET 1 and the SET POWER and SET TEMP displays will show the power and temperature values corresponding to this setting Power Control Mode The generator enters Power Control Mode if the MODE button is pressed once while the unit is in Temperature Control Mode or twice while in Stand By Mode or if a cutting or ablation probe is connected to the control unit The user may change the type and amount of power delivered by adjusting SET CUT inactive for ELECTROBLADE Resector or SET COAG inactive for GLIDER Articular Cartilage Probe All Smith amp Nephew probes are equipped with a sensor that enables the generator control unit to detect the type of probe connected When a probe is connected the Smith amp Nephew VULCAN Generator software will read the sensor and automatically adjust parameters to the pre
48. transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Applies only to Smith amp Nephew VULCAN Generator REF 7210812 Does not apply to Smith amp Nephew VULCAN Generator REF 7209673 VULCAN Generator Operations Service Manual 1061526 Rev C 29 Guidance and Manufacturer s Declaration continued Guidance and Manufacturer s Declaration Electromagnetic Immunity The Smith amp Nephew VULCAN Generator is intended for use in the electromagnetic environment specified below The customer or user of the VULCAN Generator should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 KV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the
49. warm running tap water for one minute 6 Dry the devices with a soft clean cloth 7 Autoclave using the following parameters Dry time No dry time needed Pre vac Four minutes steam exposure at 132 135 C Flash gravity Ten minutes steam exposure at 131 5 133 5 C target 132 C Note Cables may be individually wrapped in surgical kraft paper and then placed in individual sterilization pouches prior to pre vac sterilization Footswitch The footswitch may be wiped down with any liquid disinfecting solution non flammable solution should be used CAUTION Do not immerse the footswitch cable Probes Smith amp Nephew probes are disposable and are intended for single use only Do not attempt to clean or resterilize any Smith amp Nephew probe Service and Maintenance Service Philosophy There are no user serviceable components inside the generator control unit Repairs and adjustments are to be performed only by Smith amp Nephew authorized service centers If service becomes necessary call your authorized Smith amp Nephew Customer Service Representative prior to returning the device and request a Return Authorization RA number Your representative can also explain the available Service Replacement and Repair Programs Service items should be carefully repackaged and returned post paid to Smith amp Nephew Your Smith amp Nephew Customer Service Representative can provide additional i
50. y connected NEM will only illuminate when a monopolar probe is being used 8 1061526 Rev C VULCAN Generator Operations Service Manual Front Panel Layout continued BI MONOPOLAR Button The BI MONOPOLAR button selects the appropriate RF energy mode monopolar or bipolar The generator selects the appropriate mode automatically based on the probe type BI MONOPOLAR Indicator Either MONO monopolar or BIPOLAR is illuminated to identify the appropriate probe type MODE Button The MODE button selects the appropriate RF energy delivery mode Temperature Control or Power Control MODE Indicator Either TEMPERATURE Temperature Control Mode or POWER Power Control Mode is illuminated to identify the appropriate generator mode COAG Indicator Blue Light COAG illuminates when the generator control unit is delivering RF power and when the blue COAG right footswitch is pressed CUT Indicator Yellow Light CUT illuminates when the generator control unit is delivering RF power and when the yellow CUT left footswitch is pressed RF POWER ON Indicator Green Light RF POWER ON illuminates when the generator control unit is delivering RF power STAND BY Indicator Green Light STAND BY illuminates when the generator control unit is in Stand By Mode Neutral Return Electrode Connector Accepts a dual pin connector specifically designed for neutral electrode monitoring NEM Messa
51. z single phase Rated Power Input 800 VA Output Power Temperature Control Mode 50 watts 20 into 250 ohms Power Control Mode 200 watts 20 into 250 ohms Maximum Open Circuit Voltage peak to peak Temperature Control Mode 392 V Power Control Mode 1070 V Operating Frequency 460 kHz 5kHz Waveform Quasi sine wave Fuses Dual fuses T6 3AL250V RF Duty Cycle Temperature Control Mode 20 seconds on 10 seconds off Power Control Mode 5 seconds on 5 seconds off Set Temperature Range 15 99 C in Temperature Control Mode Set Power Range Temperature Control Mode 1 50 watts Power Control Mode 1 200 watts Operational Modes Power Up Stand By Ready Fault Power Delivery Modes Temperature Control Power Control Dimensions Height x Width x Depth 5 5 x 13 8 x 179 14 0 cm x 35 cm x 45 5 cm Weight 25 lbs 11 4 kg Protection Class Type BF Applied Part defibrillator proof IXPO continuous operation This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Environmental Conditions Transport and or Storage Temperature 20 60 C 10 35 C 4 40 F 50 95 F Humidity 20 90 30 75 no condensation allowed Atmospheric 500 1060 hPa 500 1060 hPa Pressure VULCAN Generator Operations Service Manual 1061526 Rev C 25 Ordering Information Ordering Infor

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